ACTIVE_NOT_RECRUITING

Decreasing Cardiovascular Risk for Patients With Diabetes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Cardiovascular disease (CVD) complications are the leading cause of diabetes mellitus (DM)-related morbidity and mortality, creating a significant burden on the public health system. This burden is, in part, attributable to poor medication adherence, with 21-42% of patients failing to properly adhere to their care. Importantly, this issue is especially pronounced in minority and low-income populations, which show higher rates of chronic illness and lower medication adherence. Interventions that foster and reinforce patient-centered communication between clinicians and patients show promise in improving health outcomes. However, they have not been widely implemented, in part due to a lack of compelling evidence for their effectiveness in primary care settings. Project Objective: The investigators propose to evaluate the impact of a patient activation program: Office Guidelines Applied to Practice (Office-GAP) combined with mobile text messaging reinforcement (Way to Health \[W2H\]) on medication adherence in patients with DM compared to mobile texting alone. Office-GAP incorporates shared decision-making and a decision/support checklist to be completed during office visits, to foster patients' investment in their own care. W2H is a texting service that informs and encourages patients to adhere to goals and improve communication. The long-term goal is to develop a model that can reliably improve and sustain adherence and can be successfully implemented in primary care clinics to close the morbidity and mortality gap for minority/low-income DM patients. The hypothesis is that the combined face-to-face patient activation and texting- delivered reinforcement methods will facilitate communication between patients and providers, improving the frequency, accuracy, and timeliness of communication while reinforcing shared goals and engendering mutual respect more than texting alone. Improved communication between patients and providers may improve medication adherence, blood sugar, cholesterol, blood pressure control, and patient satisfaction with providers, and ultimately decrease burden of illness. Research Strategy: The investigators will conduct a randomized community-based clinical trial in Federally-Qualified Health Centers (FQHCs) in Michigan enrolling 378 patients in 17 teams. All patients will receive usual care and medication for DM and CVD prevention. Eight teams will use W2H alone, and 9 teams will combine Office-GAP with WTH. The investigators will evaluate the impact of shared decision-making strategies for patients and providers. Impact: If successfully translated to clinical practice, these interventions have the potential to significantly impact patient care in FQHCs, improving outcomes for DM and CVD. This research also paves the way for shifting clinical practice across a spectrum of chronic disease where medication non-adherence is an issue.

Official Title

Improving Diabetic Patients' Adherence to Treatment and Prevention of Cardiovascular Disease

Quick Facts

Study Start:2021-05-26
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04874116

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Adesuwa Olomu, MD, MS
PRINCIPAL_INVESTIGATOR
Michigan State University

Study Locations (Sites)

Ingham Healthcare center
Lansing, Michigan, 48742
United States

Collaborators and Investigators

Sponsor: Michigan State University

  • Adesuwa Olomu, MD, MS, PRINCIPAL_INVESTIGATOR, Michigan State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-26
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2021-05-26
Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 2